Trump Admin Vows to Crack Down on Drug Ads

By Jennifer Henderson – Pharmaceutical companies will be required to include full safety warnings in direct-to-consumer ads, HHS and FDA announced Tuesday. The policy change would reverse one from 1997 that opened the door to now-ubiquitous TV drug advertising. In their announcement of the planned reform, HHS and FDA detailed that, until 1997, drug ads were "required to report full contraindications, boxed warnings, and common precautions in advertisements." Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Full safety warnings will be required in ads: HHS and FDA announced a planned rule that would require pharmaceutical companies to include full safety warnings in direct-to-consumer ads, reversing a 1997 policy that allowed vague "major-risk statements" and referrals to external sources for complete information. The change is intended to close the so-called "adequate provision" loophole that let advertisers point viewers to websites, toll-free numbers, or print inserts for fuller safety details. The agencies say the reform will present factual, legally mandated information while preserving advertisers' rights to continue commercial speech.

2. Advertising has driven higher drug spending and influenced prescribing: HHS and FDA cited estimates that advertising drove 31% of the rise in U.S. drug spending since 1997 and that people who asked doctors for a drug they saw in an ad were 17 times more likely to receive the prescription. The agencies argued that direct-to-consumer pharmaceutical ads have distorted physician prescribing habits and patient decisions. A presidential memorandum accompanying the announcement said broadcast advertising has permitted companies to include less information over time even as drug manufacturer advertising increased.

3. Enforcement and related actions are underway: The FDA said it is sending thousands of letters to pharmaceutical companies warning them to remove misleading ads and that it is issuing about 100 cease-and-desist letters to companies it said have deceptive ads. The announcement also noted other recent administration moves, including FDA guidance aimed at expanding non-opioid treatment options and prior statements about potential import taxes on pharmaceuticals. It remains uncertain how the planned rulemaking will play out legally and in practice when changes to drug ads are implemented.

New bill to extend ACA subsidies could be a test for employer health tax protection

By Allison Bell – Efforts to extend the current Affordable Care Act premium tax credit rules could be the canary that shows what will happen to efforts to protect the current employer health benefits tax exclusion. Rep. Jennifer Kiggans, R-Va., introduced the Bipartisan Premium Tax Credit Extension Act bill last week. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Extension of Enhanced Premium Tax Credits: The proposed bill would extend the expanded Affordable Care Act (ACA) premium tax credit subsidies—originally introduced as a temporary measure during the COVID-19 pandemic—through the end of 2026. These subsidies make health insurance more affordable for individuals without access to employer-based coverage, and letting them expire could result in millions losing coverage.

2. Bipartisan Support Reflects Shifting Priorities: The bill is notably backed by a bipartisan group of lawmakers, including 11 Republicans and 5 Democrats. This suggests a shift in some Republican legislators' willingness to support ACA-related provisions, which many had previously opposed, potentially indicating broader bipartisan interest in maintaining or expanding access to affordable health coverage.

3. Potential Impact on Employer Health Benefit Tax Policy: The bill’s bipartisan support may also influence future legislative efforts to preserve the existing federal tax exclusion for employer-sponsored health benefits. With budget pressures and discussions around taxing health benefits to fund programs like Social Security, the support for maintaining subsidies could signal growing bipartisan alignment on protecting certain health-related tax policies.

Trump eyes easing tariffs on pharmaceuticals: 5 notes

By Alexandra Murphy – President Donald Trump signed an executive order modifying the scope of tariffs for certain imports, including pharmaceuticals, yet some of the proposed changes are dependent on the U.S. reaching broader trade agreements, according to the White House. Read Full Article...

HVBA Article Summary

1. Selective Tariff Exemptions for Pharmaceuticals: President Trump’s executive order exempts certain pharmaceutical products—specifically those undergoing pending Section 232 investigations—from reciprocal tariffs. This measure aims to shield critical drug imports from trade retaliation while maintaining flexibility in broader trade policy enforcement.

2. Incentives for Trade Agreements: The order establishes a framework where lower tariffs on designated pharmaceutical products, including some generics and ingredients, are only granted if a foreign trading partner signs a trade agreement with the U.S. These agreements must contribute to reducing the U.S. trade deficit and address broader trade issues, effectively using tariff relief as a negotiating incentive.

3. Expansion of Administration's Trade Strategy: This move is part of a broader continuation of the Trump administration’s assertive trade strategy, which includes imposing tariffs such as 20% on Chinese goods, 25% on Mexican goods, and 35% on Canadian goods, along with levies on materials like steel, aluminum, copper, and automobiles. The executive order further authorizes the Commerce Secretary and U.S. Trade Representative to negotiate and implement agreements that could trigger tariff reductions, signaling continued use of tariffs as a strategic tool.

Frequent primary care visits cut costs for high-risk patients

By Alan Goforth – Frequent routine primary care visits for adults with high clinical complexity can reduce costs, according to a study reported in the American Journal of Managed Care. Although it helps provide preventive services, manage chronic conditions and coordinate patient care, the United States trails other high-income nations in total health care spending for primary care. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Primary Care Frequency Linked to Costs and Outcomes Across Insurance Types: The research found a clear and consistent relationship between the frequency of primary care visits and total health care costs among commercially insured adults aged 18 to 64. Similar to prior findings in Medicare populations, more regular engagement with primary care was associated with measurable cost and outcome effects, indicating that the value of routine primary care extends across different insurance types.

2. Clinical Risk Level Influences Cost Outcomes: The effect of visit frequency on health care costs varied based on a patient’s underlying clinical risk. Patients with higher clinical complexity experienced meaningful cost savings when they had more frequent, non-urgent primary care visits, likely due to better disease management and reduced need for more expensive interventions. In contrast, lower-risk patients saw increased overall spending with additional visits, primarily driven by the cost of the visits themselves rather than any offsetting reductions in downstream care.

3. Implications for Primary Care Models: These findings suggest that adopting high-touch, proactive primary care approaches—similar to those used in Medicare—may also be beneficial for higher-risk patients within commercially insured populations. By recognizing the role of clinical complexity in driving value from primary care, health care stakeholders can consider implementing more targeted, risk-based care models to improve patient outcomes while managing long-term costs.

The ICHRA conundrum: Why solving payment friction is the key

By Al Rogers – Individual Coverage Health Reimbursement Arrangement (ICHRA) adoption is growing — up nearly 34% in the past year for Applicable Large Employers (ALEs), and some cohorts showing 49% year-over-year growth. However, some brokers and employer groups remain hesitant to consider ICHRA offerings despite the predictable budgeting, cost savings and flexibility they offer. ICHRAs replace a one-size-fits-all group plan with a defined contribution model, empowering employees to purchase coverage that fits their unique healthcare needs. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Growing adoption but broker hesitancy: ICHRA adoption has risen substantially, with Applicable Large Employers reporting significant year-over-year growth, yet many brokers and employer groups remain cautious. The hesitancy stems largely from unfamiliarity with ICHRA administration compared with traditional group plans that handle enrollment, billing and servicing. Because ICHRAs can span multiple platforms and processes, brokers often view them as more complex and therefore a fallback option rather than a primary offering.

2. Payment friction creates operational and financial risks: The article outlines how payment and administrative complexity—such as employers lacking transparency into payment timeliness and employees having to pay premiums upfront and await reimbursement—can cause missed deadlines, compliance risk and financial strain. Employers need visibility into payments by employer and employee to avoid uncertainty and audit issues. Without streamlined payment flows, both employers and employees face frustration that undermines ICHRA value.

3. Automation, consolidation and visibility are key solutions: The author recommends integrating payroll automation, consolidating premium disbursements and providing real-time dashboards to simplify ICHRA premium funding and reconciliation. These measures reduce errors, accelerate reimbursements and make administration more like a traditional group plan. With accurate, automated and transparent payment infrastructure, ICHRAs can move from a fallback option to a strategic, sustainable benefits choice.

‘Denial is not a strategy in 2025’: Why this payer is calling the insurance industry broken

By Jakob Emerson – A new kind of Medicare Advantage advertisement is hitting the airwaves, one diverging from the usual scenes of seniors gleefully enjoying an outdoor activity or making a medical appointment against a backdrop of upbeat music. Instead, a more blunt framing is the centerpiece of a new national campaign from SCAN declaring that “health insurance is broken.” Read Full Article...

HVBA Article Summary

1. Campaign Addresses Widespread Senior Frustration: SCAN Health Plan launched its new marketing campaign on August 25 across television, print, radio, and digital platforms to spotlight the challenges millions of older adults face—especially delayed or denied care, unresponsive customer service, and long wait times. Through emotionally resonant ads (including one on YouTube), the campaign illustrates real-life issues like frustrating automated systems and prescription denials. The goal is to validate seniors' experiences and challenge industry complacency by bringing these normalized issues into the public eye.

2. SCAN Leverages Its Nonprofit Identity and 300,000-Member Base: As the second-largest nonprofit health plan in the U.S., SCAN covers over 300,000 members across five states, with expansion into a sixth state underway. CEO Dr. Sachin Jain, who took leadership in 2020, emphasizes transparency and internal accountability, famously urging his team to be "comfortable calling our baby ugly." By drawing from SCAN’s roots—founded in 1977 by 12 Long Beach seniors—the campaign aims to differentiate SCAN from larger, for-profit Medicare Advantage plans that have been criticized for denying care and overcharging the government.

3. More Than Just Marketing: A Push for Systemic Change: While the campaign will be tracked by standard marketing metrics such as brand awareness and enrollment growth during the Medicare Annual Enrollment Period starting October 15, SCAN leaders insist the initiative's broader ambition is to catalyze systemic healthcare reform. CEO Jain’s message—shared with 200,000 LinkedIn followers—has already drawn reactions from peers at Elevance and Aetna, reflecting a growing but still-fragmented consensus that change is needed. SCAN's leadership believes this bold, honest approach may help reestablish trust in an industry many seniors view as increasingly impersonal and broken.

FDA Demurs on GLP-1 Compounding Fight, Debuts Consumer ‘Green List’ Instead

By Annalee Armstrong – The FDA on Friday revealed a “green list” import alert for GLP-1 ingredients in an effort to slow the use of illegal active pharmaceutical ingredients in compounded versions of the weight loss drugs. While the move was a win for consumers, the action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly. Read Full Article...

HVBA Article Summary

1. FDA Tightens Oversight on GLP-1 Drug Compounding: The FDA introduced a "green list" of compounders that meet acceptable standards and source active pharmaceutical ingredients (APIs) from FDA-inspected facilities. While the agency did not ban compounding altogether, it is taking stronger action against illegal or poor-quality GLP-1 drugs entering the U.S. This move suggests the FDA is willing to tolerate some level of compounded product as long as it meets quality benchmarks, aiming to balance safety with consumer demand.

2. Market Pressure on Novo Nordisk and Eli Lilly Shares: Analysts at BMO Capital Markets predict that the FDA's actions could add downward pressure on both Novo Nordisk and Eli Lilly. Following the announcement, Novo shares fell approximately 1.5% to $54, while Lilly’s dipped by about 0.25% to $726. Novo appears more vulnerable due to the widespread availability of compounded semaglutide, which the company partly blamed for lowered earnings guidance. Novo has taken aggressive legal steps, filing 140 lawsuits and sending 1,000 cease and desist letters to protect its market share.

3. Ongoing Legal Battles and Regulatory Uncertainty: Despite the FDA removing both Lilly’s tirzepatide and Novo’s semaglutide from the drug shortage list, many compounders continue production, bolstered by consumer demand and regulatory gaps. The agency’s efforts resemble a “whack-a-mole” scenario, with enforcement still uneven. Legal disputes, including a potential court case between Novo and former partner Hims & Hers, could shape the future landscape, but for now, the compounded GLP-1 issue remains highly fluid and far from resolved.